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Drug trials: A father moves Drug Controller General of India (DCGI)

Feb 12, 2012 INDORE : In yet another complaint against the unethicaldrug trials that took place in the city, a local resident lodged a complaint with the (DCGI), Medical Council of India (MCI) and National Human Rights Commission on Saturday accusing some city-based doctors with a clinic of making his son a trial subject after keeping him in the dark.
Om Prakash Agrawal, a resident of Rajmohalla here, alleged that the people involved in the controversial drug trials kept him in the dark. He alleged that the drug had severe side-effects and the condition of his son, Nitin, continued deteriorating. “After my son failed in examination, his mental health became unstable. He was not a healthy volunteer. Then, how could the doctors conduct trial on him,” asked Agrawal.
The complainant stated that a medical store owner referred him to Dr Abhay Paliwal at his clinic in Geeta Bhawan. “Nitin was admitted in May 2010 and we were told that he would be alright in a few days. They asked me to sign on some forms, which were in English. Though I could not understand the content, I signed on it trusting the doctors. My son was admitted to the hospital for 10 days,” stated Agrawal in his complaint.
Informing that the ‘treatment’ did not yield any result as per the promise, Agrawal complained that the doctors used to take blood samples 8-10 times a day.
“We even opposed when doctors collected blood samples frequently but no one listened,” alleged Agrawal.
The complaint alleged that an Ahmedabad-based company, Intas, sponsored the trial for which approval was taken from city-based Naitik independent ethics committee and ethics committee of CHL-Apollo Hospital.
Nitin was also not insured against clinical trial liability and is still taking the medicines for his ailment. He was not given patient information sheet and a copy of informed consent form, the complainant added.
However, the doctor involved in the particular case clarified that no trial was conducted without informing patient or family member. “I do not remember the case. I have to check the records. However, no trial was conducted without taking consent of the patient or family members,” added Dr Paliwal.
After my son failed in examination, his became unstable. Then, how could the doctors conduct trial on him.

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